- PMC-309 receives safety approval for first dose cohort
(0.2mg/kg), and second dose cohort (0.5mg/kg) is currently underway
in Australia.
DAEJEON, South Korea, July 8, 2024
/PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a
clinical-stage biotech company focusing on next-generation antibody
therapeutics, announced that PMC-309, VISTA-targeting
immuno-oncology program, received safety approval for the first
dose cohort (0.2mg/kg) in Phase 1a/b clinical trial for patients
with advanced or metastatic solid tumors in Australia. The second dose cohort (0.5mg/kg)
is currently ongoing.
The first dose cohort (0.2mg/kg) of PMC-309 was initially
administered in January 2024 and
received safety approval in April
2024. Currently, the second dose cohort (0.5mg/kg) has been
administered to two patients, with the third patient scheduled to
receive treatment soon.
PMC-309 is an IgG1 monoclonal antibody specifically binding to
VISTA on immunosuppressive cells, demonstrating excellent binding
affinity at various pH conditions within the tumor microenvironment
(TME). By inhibiting VISTA, PMC-309 offers a differentiated
mechanism of action, contributing to anti-cancer effects through
the activation of T cells, monocytes, and the proliferation of M1
macrophages.
This open-label Phase 1a/b clinical trial involves a total of 67
patients and comprises two phases: Phase 1a and Phase 1b. Phase 1a includes PMC-309 monotherapy and
combination therapy with KEYTRUDA® (pembrolizumab) to determine the
maximum tolerated dose (MTD) and the recommended Phase 2 dose
(RP2D). Phase 1b will evaluate the
safety and tolerability of PMC-309 monotherapy and combination
therapy with KEYTRUDA® at the RP2D. The clinical trial is being
conducted at four institutions in Australia.
Dr. Jin-San Yoo, Chief Executive
Officer of PharmAbcine Australia Pty, the Australian subsidiary of
PharmAbcine Inc., stated, "It has been 10 years since the first
generation of immuno-oncology drugs entered the market. During this
time, these drugs have been administered to numerous cancer
patients. While some patients have benefited, many have developed
resistance, and others have passed away. The need for
next-generation immuno-oncology drugs is critical. The confirmation
of the safety of the first dose cohort of PMC-309 is just the
beginning of this trial. We look forward to gradually verifying the
safety and efficacy of PMC-309 through the planned higher dose
cohorts. We are also preparing for the combination trial of PMC-309
with KEYTRUDA® in collaboration with MSD without any delays."
He added, "We are committed to providing new treatment options
to patients suffering from the limitations of first-generation
immuno-oncology drugs."
For more information on the clinical trial, please visit
clinicaltrials.gov, identifier NCT05957081.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About PharmAbcine Inc.
PharmAbcine is a clinical stage public company developing next
generation IgG based therapeutics to treat cancer, neovascular eye
diseases, and vascular related unmet needs.
The Company's main pipeline include clinical assets olinvacimab,
PMC-403, and PMC-309.
Olinvacimab, the Company's lead asset, is ongoing a Phase 2
trial in combination with MSD's pembrolizumab for mTNBC patients in
Australia to reconfirm the
encouraging result from Phase 1b
olinvacimab plus pembrolizumab trial, delivering 50% ORR, 67% DCR,
and clean safety profile.
PMC-403 is a novel TIE2-activating antibody that stabilizes
dysfunctional leaky disorganized pathological vessels and can be
used for vascular-related eye disease, including wet AMD
(Age-related Macular Degeneration). PMC-403 is currently undergoing
Phase 1 trial for neovascular AMD patients in Korea. PMC-403 is
also being explored to expand into wider therapeutic areas related
to pathological vessels including vessel-related rare diseases and
non-rare diseases.
PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH
conditions, is an immune checkpoint regulator that targets MDSC
(myeloid derived suppressor cells) and M2 macrophages which play
pivotal role in maintaining immunosuppressive TME (Tumor
Microenvironment). Phase 1a is ongoing at multicenter in
Australia and Phase 1b in combination with MSD's pembrolizumab
PMC-309 + Pembrolizumab combo is in plan.
PMC-005, is an anti-EGFRviii IgG that only binds to EGFRviii
expressed on cancer cells and can be applied to various modalities
including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager,
and Radio-Immunotherapy.
For additional information about PharmAbcine, visit
http://www.pharmabcine.com or follow on YouTube and
LinkedIn.
For licensing deals, joint venture, co-development, and
collaboration in research or antibody discovery inquiries, please
contact:
Business Development Team
E-mail: bd@pharmabcine.com
Office line: +82 70 4279 5100
For investor relations and public relations inquiries, please
contact:
IR/PR Team
E-mail: pmc_dis@pharmabcine.com
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